Drug Evaluation Committee ICH E19 "Selective Approaches to Safety Data Collection in Certain Clinical Trials Conducted after Approval or Post-approval in the Late Phase of Development" Key Considerations for Conducting Studies - Mainly from a Data Management Perspective
November 2024
The ICH E19 Guideline provides guidance to streamline the collection of safety data from specific clinical trials conducted during late-stage development or post-approval, thereby enabling efficient trial management. This approach is expected to facilitate more efficient collection of safety data and ensure the smooth operation of clinical trials.However, if confusion arises when adapting to these non-standard operational methods, efficiency may decline, and the guidelines’ objectives may not be achieved. Therefore, proper preparation is essential.
This document explains the intent of the E19 Guidelines, outlines the necessary processes for each phase of clinical trials involving data management, and provides a practical operational guide for trials applying Selective Safety Data Collection (SSDC).The aim is to support efficient clinical trial operations through the application of SSDC and to help readers proceed with their preparations while avoiding confusion. We hope this document will be of assistance in your work.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2024 Continuing Task Force 9